TEBOFORTAN 120 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tebofortan® 120 mg

film-coated tablets

Extract ofGinkgo bilobaEGb761®

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.This medication can be obtained without a prescription for the treatment of minor conditions without the intervention of a doctor. However, you must use Tebofortancarefully to get the best results. Follow exactly the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 months of treatment.

Contents of the Package Leaflet

1. What is Tebofortan and what is it used for
2. What you need to know before taking Tebofortan
3. How to take Tebofortan
4. Possible side effects
5. Storage of Tebofortan
6. Package contents and additional information

1. What is Tebofortan and what is it used for

They are film-coated tablets with 120 mg of Ginkgo bilobaEGb 761® extract. This plant-based medication is indicated for the improvement of age-related cognitive decline.

2. What you need to know before taking Tebofortan:

Do not take Tebofortan:

• If you are allergic to Ginkgo biloba or any of the other components of this medication (listed in section 6).
• Due to the lack of clinical experience in the use of Tebofortan in children, its use is not recommended in children and adolescents under 18 years of age.
• In case of pregnancy (see Pregnancy, breastfeeding, and fertility).

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Tebofortan.

In case of increased bleeding tendency (hemorrhagic diathesis) and simultaneous treatment with anticoagulant medications, this medication should only be taken after consulting a doctor. Isolated reports indicate that preparations containing Ginkgo may increase the tendency to bleed. This medication should be discontinued before surgery. Inform your doctor in due time that you have taken Tebofortanso that they can decide how to proceed.

If you suffer from epilepsy, consult your doctor before starting treatment with Tebofortan.

You should consult a doctor if your condition worsens or does not improve.

Children and adolescents:

It should not be administered to children under 18 years of age.

Taking Tebofortan with other medications:

No clinically relevant interactions are known to date.

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Taking Tebofortan with food and beverages:

Do not take the tablets while lying down. The tablets should be swallowed without chewing with some liquid (preferably with a glass of water). The intake of the medication should be done separately from meals.

Pregnancy, breastfeeding, and fertility:

If you are pregnant, think you may be pregnant, or plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medication.

As a general precaution and due to the lack of data, this medication should not be taken during pregnancy.

No clinical data are available on its use during breastfeeding, so the use of this medication during breastfeeding is not recommended.

Driving and using machines:

No effects on driving and using machines have been reported.

Tebofortan contains lactose:

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Tebofortan contains corn starch.

3. How to take Tebofortan

This medication is used orally.

Follow exactly the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Adults over 18 years: The recommended dose is 1 tablet 2 times a day, morning and night (240 mg of Ginkgo bilobaextract per day).

Duration of treatment:

The duration of treatment should be at least 8 weeks. If symptoms worsen or do not improve after a treatment period of 3 months, you should consult your doctor about the convenience of continuing it.

If you take more Tebofortan than you should:

No cases of overdose are known. If you have taken a large number of Tebofortan tablets, the adverse reactions indicated in section 4 Possible side effectsmay be increased.

In this case, inform your doctor. They will decide what measures to take.

In cases of overdose or accidental ingestion, go to a medical center immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Tebofortan:

Do not take a double dose to make up for forgotten doses.

If you stop taking Tebofortan:

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Tebofortan can cause side effects, although not everyone experiences them.

No verified data are available on the frequency of side effects observed during treatment with preparations containing Ginkgo biloba, as these effects are only known through individual reports from patients, doctors, or pharmacists. According to these reports, the following side effects may occur during treatment with Tebofortan:

In people with hypersensitivity, anaphylactic shock or allergic skin reactions (redness, swelling, itching) may occur.

Adverse reactions mainly consist of gastrointestinal problems such as diarrhea, abdominal pain, and nausea, but also headache, dizziness, and vertigo or worsening of existing vertigo.

Isolated reports indicate bleeding from individual organs.

In case any of the above-mentioned side effects occur, do not take more Tebofortan and consult your doctor so that they can decide on the severity and possibly the measures to be taken.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tebofortan

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the label and box after Expiration:. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point of your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

No special storage conditions are required.

6. Package contents and additional information:

Composition of Tebofortan per tablet:

The active ingredient is 120.0 mg of dry extract of Ginkgo biloba leaves EGb 761® (plant dry extract ratio: 35-67:1), obtained with 60% w/w acetone, quantified to 26.4 – 32.4 mg of flavonoids calculated as flavonoid glycosides and to 6.48 – 7.92 mg of terpene lactones, of which 3.36 – 4.08 mg are ginkgolides A, B, and C, and 3.12 – 3.84 mg are bilobalides and no more than 0.6 micrograms are ginkgolic acids.

The other components are sodium croscarmellose, colloidal silicon dioxide, hypromellose, lactose monohydrate, macrogol 1500, magnesium stearate, corn starch, microcrystalline cellulose, dimethicone, alpha-octadecyl-omega-hydroxypoly(oxyethylene)5, sorbic acid (E-200), talc, and iron oxide red (E-172) colorant.

Appearance of the product and package contents:

Red, round, film-coated tablets. Tebofortan 120 mg is presented in cardboard boxes containing 15, 30, 45, or 60 tablets in blisters.

Marketing authorization holder and manufacturer:

Dr. Willmar Schwabe GmbH & Co.KG

Willmar-Schwabe-Straße 4

76227 Karlsruhe / Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Local representative:

SCHWABE FARMA IBÉRICA, S.A.U.

Avenida de la Industria, 4. Edificio 2, escalera 1, 2ª planta. 28108 Alcobendas, Madrid

Date of the last revision of this package leaflet: September 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.